Study to Evaluate Safety and Efficacy of Filgotinib and Lanraplenib in Females With Moderately-to-Severely Active Cutaneous Lupus Erythematosus (CLE)

A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Filgotinib and GS-9876 in Female Subjects With Moderately-to-Severely Active Cutaneous Lupus Erythematosus (CLE)

The primary objective of this study is to evaluate the efficacy of filgotinib and lanraplenib (formerly GS-9876) in females with moderately-to-severely active cutaneous lupus erythematosus (CLE).

Study Overview

• Status: Completed
• Conditions: Cutaneous Lupus Erythematosus
• Intervention / Treatment: Drug: Lanraplenib; Drug: Filgotinib placebo; Drug: Filgotinib; Drug: Lanraplenib placebo

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ottawa, Canada, K2C 3N2
    • Dermatology Ottawa Research Centre
  • Toronto, Canada, M5T 2S8
    • University Health Network (UHN) - Toronto Western Hospital
  • Waterloo, Canada, N2J 1C4
    • K.Papp Clinical Research
• United States
  • California
    • Beverly Hills, California, United States, 90211
      • Wallace Rheumatic Studies Center
    • Fullerton, California, United States, 92835
      • St. Jude Hospital Yorba Linda DBA Dr. Joseph Heritage Healthcare
    • Los Angeles, California, United States, 90045
      • Dermatology Research Associates
    • Palm Desert, California, United States, 92260
      • Desert Medical Advances
    • San Diego, California, United States, 92103
      • MedDerm Associates
    • Upland, California, United States, 91786
      • Inland Rheumatology Clinical Trials
  • Florida
    • Clearwater, Florida, United States, 33765
      • Clinical Research of West Florida, Inc.
    • DeBary, Florida, United States, 32713
      • Omega Research Consultants LLC
  • North Carolina
    • Charlotte, North Carolina, United States, 28210
      • DJL Clinical Research, PLLC
    • Winston-Salem, North Carolina, United States, 27104
      • Wake Forest University Health Sciences
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Hershey Medical Center
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
  • Texas
    • Dallas, Texas, United States, 75231
      • Metroplex Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Key Inclusion Criteria:

• Must have a diagnosis of CLE, either chronic (e.g., discoid) or subacute CLE per investigator evaluation, with the following:

  • Moderately-to-severely active CLE (Cutaneous lupus erythematosus disease area and severity index [CLASI] activity score ≥ 10) at screening and Day 1
  • Prior intolerance or inadequate response to at least one of the listed medications for the treatment of CLE
• Stable dose (defined as no change in prescription for at least 28 days prior to Day 1) of antimalarials and/or topical or oral corticosteroids is permitted during the study. Individuals who are not planning to continue these medications during the study must have discontinued them at least 28 days prior to Day 1

Key Exclusion Criteria:

• Use of prohibited concomitant medications per study protocol

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lanraplenib 30 mg; Lanraplenib + filgotinib placebo for 48 weeks	Drug: Lanraplenib; 30 mg tablets administered orally once daily with or without food; Other Names: GS-9876; Drug: Filgotinib placebo; Tablets administered orally once daily with or without food
Experimental: Filgotinib 200 mg; Filgotinib + lanraplenib placebo for 48 weeks	Drug: Filgotinib; 200 mg tablets administered orally once daily with or without food; Other Names: GS-6034; Drug: Lanraplenib placebo; Tablets administered orally once daily with or without food
Placebo Comparator: Placebo; Filgotinib placebo + lanraplenib placebo for 12 weeks	Drug: Filgotinib placebo; Tablets administered orally once daily with or without food; Drug: Lanraplenib placebo; Tablets administered orally once daily with or without food
Experimental: Placebo to Lanraplenib 30 mg; After Week 12 Visit, participants on placebo will be rerandomized 1:1 and receive lanraplenib + filgotinib placebo in a blinded fashion through Week 48.	Drug: Lanraplenib; 30 mg tablets administered orally once daily with or without food; Other Names: GS-9876; Drug: Filgotinib placebo; Tablets administered orally once daily with or without food
Experimental: Placebo to Filgotinib 200 mg; After Week 12 Visit, participants on placebo will be rerandomized 1:1 and receive filgotinib + lanraplenib placebo in a blinded fashion through Week 48.	Drug: Filgotinib; 200 mg tablets administered orally once daily with or without food; Other Names: GS-6034; Drug: Lanraplenib placebo; Tablets administered orally once daily with or without food

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score From Baseline to Week 12	CLASI Activity is scored based on erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and nonscarring alopecia. Evaluation of erythema and scale/hyperkeratosis is based on a table: rows represent anatomical areas and columns represent major clinical symptoms. The extent of involvement for each of the skin symptoms is documented for each anatomic area. The total score ranges from 0-70, with higher scores indicating more severe skin disease.	Baseline; Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants at Week 12 With Decrease of ≥ 5 Points in CLASI Activity Score From Baseline	CLASI Activity is scored based on erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and nonscarring alopecia. Evaluation of erythema and scale/hyperkeratosis is based on a table: rows represent anatomical areas and columns represent major clinical symptoms. The extent of involvement for each of the skin symptoms is documented for each anatomic area. The total score ranges from 0-70, with higher scores indicating more severe skin disease.	Baseline; Week 12
Percentage of Participants at Week 12 With No Worsening in CLASI Activity Score From Baseline	CLASI Activity is scored based on erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and nonscarring alopecia. Evaluation of erythema and scale/hyperkeratosis is based on a table: rows represent anatomical areas and columns represent major clinical symptoms. The extent of involvement for each of the skin symptoms is documented for each anatomic area. The total score ranges from 0-70, with higher scores indicating more severe skin disease. Worsening was defined as ≥ 3 point increase in CLASI activity score.	Baseline; Week 12
Percentage of Participants at Week 24 With Decrease of ≥ 5 Points in CLASI Activity Score From Baseline	CLASI Activity is scored based on erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and nonscarring alopecia. Evaluation of erythema and scale/hyperkeratosis is based on a table: rows represent anatomical areas and columns represent major clinical symptoms. The extent of involvement for each of the skin symptoms is documented for each anatomic area. The total score ranges from 0-70, with higher scores indicating more severe skin disease.	Baseline; Week 24
Percentage of Participants at Week 24 With No Worsening in CLASI Activity Score From Baseline	CLASI Activity is scored based on erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and nonscarring alopecia. Evaluation of erythema and scale/hyperkeratosis is based on a table: rows represent anatomical areas and columns represent major clinical symptoms. The extent of involvement for each of the skin symptoms is documented for each anatomic area. The total score ranges from 0-70, with higher scores indicating more severe skin disease. Worsening was defined as ≥ 3 point increase in CLASI activity score.	Baseline; Week 24

Collaborators and Investigators

• Sponsor: Gilead Sciences
• Collaborators: Galapagos NV

Publications and helpful links

General Publications

• Werth VP, Fleischmann R, Robern M, Touma Z, Tiamiyu I, Gurtovaya O, Pechonkina A, Mozaffarian A, Downie B, Matzkies F, Wallace D. Filgotinib or lanraplenib in moderate to severe cutaneous lupus erythematosus: a phase 2, randomized, double-blind, placebo-controlled study. Rheumatology (Oxford). 2022 May 30;61(6):2413-2423. doi: 10.1093/rheumatology/keab685.

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2017
• Primary Completion (Actual): March 13, 2019
• Study Completion (Actual): December 18, 2019

Study Registration Dates

• First Submitted: April 25, 2017
• First Submitted That Met QC Criteria: April 25, 2017
• First Posted (Actual): April 28, 2017

Study Record Updates

• Last Update Posted (Actual): June 9, 2020
• Last Update Submitted That Met QC Criteria: June 1, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic; Lupus Erythematosus, Cutaneous
• Other Study ID Numbers: GS-US-436-4092

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No